Obesity PreventionNCT06767072
Effectiveness of Tailored Multichannel Interventions on Weight Loss Among Adolescents: A Randomized Controlled Trial
A study testing Tailored Multichannel interventions in people with Obesity Prevention and Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
overweight among adolescents is a public health issue. However, several weight loss interventions were developed and conducted for adolescents. These interventions are often not adequately tailored to the needs of this vulnerable target group. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention, Obesity, Overweight Adolescents
- What is being tested?
- Tailored Multichannel interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2025to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Students in the first and second grades of college whose body mass index (BMI) of 25 or higher at the baseline assessment will be eligible to participate in the study.
Who cannot join
- Students will be excluded if they have one of the following criteria.
- Students who report a physical condition or chronic illness or impairment preventing them from being physically active
- Students who have physical conditions that prevent them from losing excess body weight
- Students who are on medication that causes weight gain
- Students with a history of mental health disorders
- Students participating in another weight loss program
Trial locations and contacts
1 site in 1 country.
About this study
overweight among adolescents is a public health issue. However, several weight loss interventions were developed and conducted for adolescents. These interventions are often not adequately tailored to the needs of this vulnerable target group. Besides, these interventions proposed one channel is adequate to deliver the message to adolescents.
The proposed study aims to evaluate the effectiveness of tailored multichannel interventions on weight loss among adolescents.
The proposed study is a prospective, cluster-randomized controlled trial. 279 adolescents will be recruited from 8 non-medical colleges in Mansoura University. The 8 colleges will be randomly assigned to 4 colleges for the tailored multichannel nursing intervention or 4 colleges as a control group. For intervention participants, the tailor-based intervention will be designed and guided by a health belief model and take into evidence-based recommendations. The intervention will be designed by a multidisciplinary team and will be administered by 8 nurses for 5 months, including five face-to-face school meetings, five school-based telephone calls, and five WhatsApp text messages. Control group participants will receive 2 non-tailored face-to-face sessions. The primary outcome is the mean difference in weight loss between groups. The proposed study hypothesizes that the participants who will receive tailored multichannel intervention will lose significantly more weight (Body Mass Index) compared with the control group. Secondary outcomes include a health belief model.
Read the detailed description
Overweight and obesity and their related consequences are largely preventable and manageable. However, overweight is one of the most common health problems in the world. World Health Organization (WHO) reported that 12.5 % of people worldwide are overweight according to a survey of the global burden of diseases conducted in 2022. Furthermore, worldwide adult obesity has more than doubled since 1990, and adolescent obesity has quadrupled. WHO, 2024 reported that 390 million children and adolescents aged 5-19 years were overweight including 160 million who were living with obesity. Overweight and obesity are significantly correlated with an increased risk of several health disorders, such as cardiovascular disease, psychological disturbance, metabolic syndrome, type 2 diabetes, fatty liver disease, and premature death. Obesity also imposes enormous financial burdens on governments and individuals. Adolescence obesity is of particular concern as it has increased globally, and it could have adverse health impacts in adulthood.
Overall, the global prevalence of adolescent obesity is a growing public health concern, with significant physical and psychological consequences. Adolescence is a critical period where dietary habits and lifestyle behaviors are shaped, making it an ideal time for interventions aimed at promoting healthy weight management. Several preventive and treatment interventions have been conducted to enhance weight control among adolescents in different countries. However, the effectiveness of past interventions has shown inconsistent outcomes. Compliance with weight-loss treatments varies for a range of reasons, mainly related to the design and delivery of the interventions.
Systematic reviews reveal debate regarding how best to motivate adolescents to manage their ideal body weight. Empirical evidence shows that tailored interventions are often considered more effective than standardized interventions for reducing overweight among adolescents. Tailored interventions account for individual differences in lifestyle, preferences, perceptions about health and obesity, and self-efficacy. Previous studies have shown that these factors play important roles in the success of weight loss and maintenance programs. While standardized interventions can provide a solid foundation, tailoring strategies to individual needs often leads to more sustainable behavior changes and better health outcomes. Tailored interventions consider each adolescent's unique motivations, preferences, and challenges. This personalization can lead to greater engagement and adherence.
The literature suggests that interventions delivered through multiple channels-such as social media, face-to-face interactions, and telephone calls-are often more effective in addressing overweight and obesity among adolescents. Adolescents are highly engaged with digital platforms like social media, making it a natural channel of communication and providing daily reminders or motivation. Incorporating face-to-face interactions builds a personal connection and offers in-depth discussions, while telephone calls provide a direct and accessible line of communication.
- Conditions
- Obesity Prevention, Obesity, Overweight Adolescents, Overweight/Obesity, Adolescent, BMI, Behaviour Change
- Being tested
- Tailored Multichannel interventions
- Keywords
- digital intervention., overweight, adolescents, tailored, health belief model, multichannel, face-to-face college meetings, telephone calls, WhatsApp text messages, and digital intervention.
- Medical subject headings
- Obesity, Overweight, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Multichannel interventionsBehavioural
To ensure the feasibility of the intervention, the intervention will be designed by an interdisciplinary team including academic researchers from different specialties (experts in the fields of community health, psychiatry health, and nutrition), as well as 3 research assistants.
The designing process for each individual in the intervention group involved the following 4 subsequent steps: (1) intervention nurses assess HBM constructs, which are used to collect data on each unique perception regarding overweight(Saghafi-Asl et al., 2020). (2) data are reviewed, identified, and summarized by the interdisciplinary team; (3) the interdisciplinary team then creates an intervention plan based on the summarized needs and (4) the intervention plan will be shared with the participant to ensure collaboration.
The intervention will adopt the strategies of the Diabetes Prevention Program (DDP) (The Diabetes Prevention Program (DPP), 1996).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The CG is provided general information on overweight and obesity, and general advice to manage their weight. these will be explained to them during two college visits. CG participants will not receive tailored multichannel interventions. |
| Intervention Group | Experimental | the intervention group will receive the Tailored Multichannel interventions that will be designed by an interdisciplinary team including academic researchers from different specialties.
The proposed intervention will be administered by 8 intervention nurses via multiple channels.
The current intervention will be delivered using the various modes for 5 months Receives: Behavioral: Tailored Multichannel interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Weight in kg and height in cm will be assessed. BMI will be measured, calculated, and interpreted based on WHO guidelines and using BMI charts. Overweight is considered when a BMI is 25 kg/m2 and Obesity is equivalent to a BMI of 30 kg/m2 or over (WHO, 2024).
Measured: All data related to primary and secondary outcomes will be collected at baseline (T0) at 2 (T1) months, and 5 months (T2) after the start of intervention.
Secondary outcomes (1)
Health belief model construct
The key constructs of the HBM include 89 statements.(Jones et al., 2015) (Albasheer et al., 2024). Each statement will be rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). 13 questions evaluated perceived severity on three subscales (emotional/mental, health, physical health/fitness, and social professional). 7 questions evaluated perceived susceptibility and consisted of two subscales (lifestyle and environmental). 14 questions dealt with perceived barriers, comprising three subscales (practical concerns, emotional/mental health, and awareness). 13 questions on perceived benefits included three subscales (emotional/mental health, physical health/fitness, and social/professional). The 12 questions on cues to action consisted of two subscales (internal and external cues to action). 18 questions assessed self-efficacy in dieting and included two subscales (habits, preferences and emotional/mental health). The 7 questions on self-efficacy in exerc
Measured: All data related to primary and secondary outcomes will be collected at baseline (T0) at 2 (T1) months, and 5 months (T2) after the start of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start12 Jan 2025
- Primary completion2 Jul 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, open label, barreled two groups. the study participants will be assigned randomly to intervention group or control group. the participants in the the intervention group will receive the tailored Multichannel Interventions, while the control group will receive two supportive session. the intervention group will not receive the tailored multichannel intervention.
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University, Mansoura University, British University In Egypt, Port Said University
- Responsible party
- Principal investigator, Mahmoud Ahmed Ahmed Ahmed Elsheikh, Cairo University
- Investigators
- M A ELSHEIKH, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767072
- Sponsor's protocol ID
- IRB0689
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the investigators intended to share all data as ICMJE policy. IPD will be shared after the completion of the study. Data repository platform will be decided later.
Publications
Elsheikh MA, Zoromba MA, Selim T, Atta MHR, Mohamed NF, Abdelazim SO, El-Gazar HE, Albasheer O, Abousoliman AD, Abdallah LS. Effectiveness of tailored multichannel interventions on weight loss among adolescents: a randomized controlled trial. Front Public Health. 2026 Mar 27;14:1733027. doi: 10.3389/fpubh.2026.1733027. eCollection 2026.
PubMed 41971264
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tailored Multichannel Interventions on Weight Loss Among Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06767072
- Acronym / sponsor ID
- IRB0689
- Conditions
- Obesity Prevention, Obesity, Overweight Adolescents, Overweight/Obesity, Adolescent, BMI, Behaviour Change
- Keywords
- digital intervention., overweight, adolescents, tailored, health belief model, multichannel, face-to-face college meetings, telephone calls, WhatsApp text messages, and digital intervention.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University, Mansoura University, British University In Egypt, Port Said University
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- 2 Jul 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
overweight among adolescents is a public health issue. However, several weight loss interventions were developed and conducted for adolescents. These interventions are often not adequately tailored to the needs of this vulnerable target group. Besides, these interventions proposed one channel is adequate to deliver the message to adolescents.
The proposed study aims to evaluate the effectiveness of tailored multichannel interventions on weight loss among adolescents.
The proposed study is a prospective, cluster-randomized controlled trial. 279 adolescents will be recruited from 8 non-medical colleges in Mansoura University. The 8 colleges will be randomly assigned to 4 colleges for the tailored multichannel nursing intervention or 4 colleges as a control group. For intervention participants, the tailor-based intervention will be designed and guided by a health belief model and take into evidence-based recommendations. The intervention will be designed by a multidisciplinary team and will be administered by 8 nurses for 5 months, including five face-to-face school meetings, five school-based telephone calls, and five WhatsApp text messages. Control group participants will receive 2 non-tailored face-to-face sessions. The primary outcome is the mean difference in weight loss between groups. The proposed study hypothesizes that the participants who will receive tailored multichannel intervention will lose significantly more weight (Body Mass Index) compared with the control group. Secondary outcomes include a health belief model.
Detailed description
Overweight and obesity and their related consequences are largely preventable and manageable. However, overweight is one of the most common health problems in the world. World Health Organization (WHO) reported that 12.5 % of people worldwide are overweight according to a survey of the global burden of diseases conducted in 2022. Furthermore, worldwide adult obesity has more than doubled since 1990, and adolescent obesity has quadrupled. WHO, 2024 reported that 390 million children and adolescents aged 5-19 years were overweight including 160 million who were living with obesity. Overweight and obesity are significantly correlated with an increased risk of several health disorders, such as cardiovascular disease, psychological disturbance, metabolic syndrome, type 2 diabetes, fatty liver disease, and premature death. Obesity also imposes enormous financial burdens on governments and individuals. Adolescence obesity is of particular concern as it has increased globally, and it could have adverse health impacts in adulthood.
Overall, the global prevalence of adolescent obesity is a growing public health concern, with significant physical and psychological consequences. Adolescence is a critical period where dietary habits and lifestyle behaviors are shaped, making it an ideal time for interventions aimed at promoting healthy weight management. Several preventive and treatment interventions have been conducted to enhance weight control among adolescents in different countries. However, the effectiveness of past interventions has shown inconsistent outcomes. Compliance with weight-loss treatments varies for a range of reasons, mainly related to the design and delivery of the interventions.
Systematic reviews reveal debate regarding how best to motivate adolescents to manage their ideal body weight. Empirical evidence shows that tailored interventions are often considered more effective than standardized interventions for reducing overweight among adolescents. Tailored interventions account for individual differences in lifestyle, preferences, perceptions about health and obesity, and self-efficacy. Previous studies have shown that these factors play important roles in the success of weight loss and maintenance programs. While standardized interventions can provide a solid foundation, tailoring strategies to individual needs often leads to more sustainable behavior changes and better health outcomes. Tailored interventions consider each adolescent's unique motivations, preferences, and challenges. This personalization can lead to greater engagement and adherence.
The literature suggests that interventions delivered through multiple channels-such as social media, face-to-face interactions, and telephone calls-are often more effective in addressing overweight and obesity among adolescents. Adolescents are highly engaged with digital platforms like social media, making it a natural channel of communication and providing daily reminders or motivation. Incorporating face-to-face interactions builds a personal connection and offers in-depth discussions, while telephone calls provide a direct and accessible line of communication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, open label, barreled two groups. the study participants will be assigned randomly to intervention group or control group. the participants in the the intervention group will receive the tailored Multichannel Interventions, while the control group will receive two supportive session. the intervention group will not receive the tailored multichannel intervention.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The CG is provided general information on overweight and obesity, and general advice to manage their weight. these will be explained to them during two college visits. CG participants will not receive tailored multichannel interventions. |
| Intervention Group | Experimental | Behavioral: Tailored Multichannel interventionsthe intervention group will receive the Tailored Multichannel interventions that will be designed by an interdisciplinary team including academic researchers from different specialties. The proposed intervention will be administered by 8 intervention nurses via multiple channels. The current intervention will be delivered using the various modes for 5 months |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Students in the first and second grades of college whose body mass index (BMI) of 25 or higher at the baseline assessment will be eligible to participate in the study.
Key exclusion criteria (6 listed)
- Students will be excluded if they have one of the following criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Multichannel interventionsTo ensure the feasibility of the intervention, the intervention will be designed by an interdisciplinary team including academic researchers from different specialties (experts in the fields of community health, psychiatry health, and nutrition), as well as 3 research assistants. The designing process for each individual in the intervention group involved the following 4 subsequent steps: (1) intervention nurses assess HBM constructs, which are used to collect data on each unique perception regarding overweight(Saghafi-Asl et al., 2020). (2) data are reviewed, identified, and summarized by the interdisciplinary team; (3) the interdisciplinary team then creates an intervention plan based on the summarized needs and (4) the intervention plan will be shared with the participant to ensure collaboration. The intervention will adopt the strategies of the Diabetes Prevention Program (DDP) (The Diabetes Prevention Program (DPP), 1996). | Behavioural | Intervention Group |
Primary outcome
BMI
Time frame: All data related to primary and secondary outcomes will be collected at baseline (T0) at 2 (T1) months, and 5 months (T2) after the start of intervention.
Weight in kg and height in cm will be assessed. BMI will be measured, calculated, and interpreted based on WHO guidelines and using BMI charts. Overweight is considered when a BMI is 25 kg/m2 and Obesity is equivalent to a BMI of 30 kg/m2 or over (WHO, 2024).
1 secondary outcome
Health belief model construct
Time frame: All data related to primary and secondary outcomes will be collected at baseline (T0) at 2 (T1) months, and 5 months (T2) after the start of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 41971264Elsheikh MA, Zoromba MA, Selim T, Atta MHR, Mohamed NF, Abdelazim SO, El-Gazar HE, Albasheer O, Abousoliman AD, Abdallah LS. Effectiveness of tailored multichannel interventions on weight loss among adolescents: a randomized controlled trial. Front Public Health. 2026 Mar 27;14:1733027. doi: 10.3389/fpubh.2026.1733027. eCollection 2026.
- Individual participant dataSharing planned: Undecided. the investigators intended to share all data as ICMJE policy. IPD will be shared after the completion of the study. Data repository platform will be decided later.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M A ELSHEIKH, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Multichannel interventions in people with Obesity Prevention and Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: All data related to primary and secondary outcomes will be collected at baseline (T0) at 2 (T1) months, and 5 months (T2) after the start of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06767072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.